Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients

August 23, 2021 updated by: Birgitte Offersen, Danish Breast Cancer Cooperative Group

Hypofractionated Versus Standard Fractionated Whole Breast Irradiation to Node-negative Breast Cancer Patients: a Randomized Phase III Trial, CIRRO (The Lundbeck Foundation Center for International Research in Radiation Oncology)

The purpose of this study is to investigate the difference in late radiation morbidity between hypofractionated and standard fractionated breast irradiation given to women operated with breast conservation for early breast cancer.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The randomization is between 50 Gy/25 fractions, 2.0 Gy per fraction, 5 fractions weekly, and 40 Gy/15 fractions, 2.67 Gy per fraction, 5 fractions weekly. The primary endpoint is late radiation morbidity; secondly, we want to investigate the frequency of local recurrences, and try to establish a genetic risk profile for development of late radiation morbidity.

The hypothesis is that women operated with breast conserving strategy for early breast cancer can be offered moderately hypofractionated radiotherapy without developing more late radiation morbidity compared to standard fractionated radiotherapy.

Study Type

Interventional

Enrollment (Anticipated)

976

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, DK-2100 Ø
        • The Danish Breast Cancer Cooperative Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • operated with breast conserving strategy for:

    1. invasive breast cancer, pT1-2, pN0-1mi, M0 OR
    2. carcinoma in situ of the breast

Exclusion Criteria:

  • previous radiation of the breast/thorax
  • breast implants
  • pregnant/lactating
  • comorbidity which may hinder the patient in completing the therapy and complete follow up for 10 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: standard fractionated radiotherapy
50 Gy/25 fractions, 2.00 Gy/fraction, 5 fractions per week
Radiation: standard fractionated radiotherapy
standard fractionated radiotherapy 50 Gy/25 fractions
Experimental: hypofractionated radiotherapy
hypofractionated radiotherapy 40 Gy/15 fractions
Radiation: hypofractionated radiotherapy
hypofractionated radiotherapy 40 Gy/15 fractions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Grade 2 or 3 fibrosis 3 years after radiotherapy
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Breast Cancer Cooperative Group

Collaborators

Danish Cancer Society

Investigators

  • Study Chair: Birgitte Offersen, MD, Ph.D, Aarhus University Hospital
  • Study Chair: Erik Jakobsen, MD, Vejle Hospital
  • Study Chair: Mechthild Krause, M.D., Prof, University Clinic Carl Gustav Carus Dresden
  • Study Chair: Andreas Schreiber, M.D., Ph.D., Praxis für Strahlentherapie am Klinikum Dresden-Friedrichstadt
  • Study Chair: Ingvil Mjaaland, M.D., Helse Stavanger HF, Sorlandet Sykehus HF
  • Study Chair: Unn-Miriam Kasti, M.D., Kristiansand sykehus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2009

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

May 28, 2009

First Submitted That Met QC Criteria

May 28, 2009

First Posted (Estimate)

May 29, 2009

Study Record Updates

Last Update Posted (Actual)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DBCG hypo protocol
  • CIRRO IP030209
  • The Danish Cancer Society

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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